BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1111534 · Received August 13, 2008

    Report

    Report Number
    2953144-2008-01313
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: VESSEL LOCATOR WINGS FAILED TO RETRACT/DIFFICULT TO REMOVE. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A TRAINED PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY USING A STARCLOSE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE CLIP WAS DEPLOYED, THE DEVICE REMAINED IN THE GROIN. THE SAFETY RELEASE AND VESSEL LOCATOR BUTTONS WERE DEPRESSED BUT THE DEVICE COULD NOT BE REMOVED. A FLUOROSCOPY OF THE GROIN WAS PERFORMED AND THE VESSEL LOCATOR WINGS WERE PARTIALLY OPENED. THE DEVICE WAS REMOVED WITH THE LEFT HAND POSITIONED ON THE GROIN AND THE RIGHT HAND POSITIONED ON THE DEVICE. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 66111-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention